Data Management Sr Manager - Quality

Medtronic   •  

Mounds View, MN

8 - 10 years

Posted 178 days ago

This job is no longer available.

Careers that Change Lives 

 
Together, we can change healthcare worldwide. At Medtronic, We push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
 
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

A Day in the Life
Lead the Global (Cardiac and Vascular Group) CVG Quality data management team. This leader will work in collaboration with all CVG Quality functional leaders and business unit stakeholders to define, develop and implement the Quality data management strategy as it related Quality performance metrics.   In tandem, drive continuous improvement, and operational excellence in our process and associated tools through the execution of selected initiatives year on year.   This leader will lead the team that synthesizes large volumes of quality data into meaningful information, producing reports, and provide actionable recommendations based on data that will be presented to both CVG Quality Leadership and broader Medtronic leaders to support key business and quality decisions.    This role reports directly to the vice president of CVG Quality - Core Quality Services (CQS).

Responsibilities may include the following and other duties may be assigned.

  • Lead the development and execution of CVG Global Quality Data management vision and strategy.
  • Lead a team of comprising of both business analysts and developers that support the CVG Quality data management system whose responsibilities will include: 
  • Tasks to develop, inspect, mine, transform, and model data to assess Quality performance, improve decision making, confirm strategy is effective.
  • Conducts statistical analysis on data and information to ensure correct predictive forecasting or classification.
  • Work closely with cross functional partners to understand and predict data trends as an input to overall organization demand planning.
  • Manages all aspects of end-to-end quality data processing utilizing customized report building functions of systems.
  • Providing standard and non-standard reports to supportinternal and external inspections, QMR’s and other management meetings.
  • Maintains quality data analytical systems, verifies the accuracy of the data.
  • Develop, maintain and communicate metrics monthly, quarterly and annually.
  • Creating and maintaining system interfaces and reports that enable track and trend work more effectively and efficiently.
  • Partner with the Global IT development team to ensure accuracy and completeness of database design, validation and verification in line with Medtronic requirements and related applicable Data integrity regulations.
  • Ensure that team members are current in industry best practices. 
  • Maintaining awareness of new technology and best practices via reading, formal course work, membership in professional organizations, etc. 
  • Providing technical trouble shooting support:
  • Maintain open and frequent lines of communication with key Quality leaders / partners in Groups, Businesses and Regions – building relationships and exercising influence to ensure alignment across the company.
  • Manage specific projects as assigned related to analyzing quality and financial data. 
  • Lead the Global Quality Data Management sub- council.
  • Lead development of procedures and drives the development of standard operating procedures and associated training to ensure the quality of quality data management processes.
  • Maintain a broad theoretical understanding of current processes and methods as well as trends and directions of the Quality Data Management.
  • Prioritize ongoing projects for the group and align group’s tasks with company’s strategic goals.
  • Assess staffing and organizational needs; mentor, develop statistical expertise, continue to improve efficiency and effectiveness of the data analytics group.
  • Responsible for the performance of the Data Management team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget.
  • Responsible for the performance and the development of each data management team member ensuring that Data Management staff successfully interfaces with business units and other key functional groups / leadership to drive quality and cross-functional initiatives.
  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Co-ordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Must Have: Minimum Requirements

REQUIRED EDUCATION: 

  • BA/BS degree

 REQUIRED YEARS OF EXPERIENCE:  

  • 7+ years of experience in business intelligence, financial or technical analysis experience.
  • 5+ years of people/ project leadership experience

Nice to Have

  • Competency in Statistical analysis methods/tools
  • Proficiency in report creation (Tableau, Business Objects)
  • Proven ability to work cross functionally required
  • Presenting to senior executives
  • Experience with data preparation, rationalization, and processing with a Working knowledge of business analysis methodologies and application – i.e. Oracle DB, SQL, VB etc.
  • Experience analyzing and calculating data in partnership with internal constituencies, which involves the design of spreadsheets, databases, and presentations for use in senior management meetings
  • Advanced expertise with data collection, analytics and visualization tools
  • Experience with technical aspects of data warehousing and coding
  • Experience with Quality processes and metrics (Quality System, Ops Quality etc.)
  • Strong interpersonal skills, team player, and flexible without compromising quality
  • Working knowledge of statistical tools and models
  • Experience working withfinancial data
  • Prior experience interfacing with FDA
  • Knowledge and understating of Medical Device Regulation and Quality Assurance (e.g.) ISO9001, ISO 13485, ISO14971, IEC 60601; FDA 21 CRF820.30. and other associated Data integrity and software validation requirements
  • Experience in risk management
  • Experience with personal computer software (Microsoft Office)
  • Superior interpersonal, written and oral communication skills
  • Ability to successfully balance and prioritize multiple ongoing projects/tasks
  • Strong attention to detail and accuracy
  • High degree of initiative and self-motivation
  • Strong analytical skills and ability to solve problems through analytical reasoning
  • 5+ years of experience in the medical device industry


About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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